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Global Active Pharmaceutical Ingredient (API) Market Report and Forecast 2023-2031
Market Report I 2023-04-18 I 147 Pages I EMR Inc.
Global Active Pharmaceutical Ingredient Market Report and Forecast 2023-2031
Global Active Pharmaceutical Ingredient Market Outlook:
The global active pharmaceutical ingredient market value was USD 205.9 billion in 2022, driven by the increasing prevalence of diseases across the globe. The market size is anticipated to grow at a CAGR of 5.5% during the forecast period of 2023-2031 to achieve a value of USD 333.4 billion by 2031.
Active Pharmaceutical Ingredient: Introduction
Active Pharmaceutical Ingredients (APIs) are the primary active substances used in the formulation of pharmaceutical drugs. They are responsible for the therapeutic effects of the medication and are carefully selected based on their biological activity and safety profile. APIs can be obtained from natural sources, such as plants or animals, or synthesized through chemical processes.
APIs play a crucial role in the pharmaceutical industry, as they form the core component of drug formulations. They are responsible for the intended pharmacological action and desired therapeutic outcomes. APIs undergo rigorous testing and quality control measures to ensure their safety, efficacy, and compliance with regulatory standards.
The market for APIs is driven by factors such as the increasing prevalence of diseases, the growing demand for effective medications, and advancements in drug research and development. The pharmaceutical industry relies heavily on APIs to produce a wide range of drugs, including prescription medications, over-the-counter drugs, and generic drugs.
Key Trends in the Active Pharmaceutical Ingredient Market
Some key trends in the active pharmaceutical ingredient market are:
- Increasing demand for generic drugs: The rising cost of branded medications and the expiration of patents for many blockbuster drugs have fueled the demand for generic drugs. This has led to an increased focus on the production of cost-effective APIs to support the generic drug market.
- Shift towards biologics and biosimilars: The development of biologics, including monoclonal antibodies and recombinant proteins, has gained significant momentum. APIs for biologics are produced using biotechnological processes, such as cell culture and genetic engineering. The market is also witnessing the emergence of biosimilars, which are similar versions of biologic drugs. This trend has created opportunities for API manufacturers specializing in biologics and biosimilars.
- Increased regulatory scrutiny: Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have strengthened their oversight of API manufacturing. They require manufacturers to comply with stringent quality control measures, good manufacturing practices (GMP), and quality assurance standards. This focus on quality and safety has influenced the API market, leading to improved manufacturing practices and increased investments in quality management systems.
- Growing emphasis on sustainability: The pharmaceutical industry is increasingly recognizing the importance of sustainable practices in API manufacturing. There is a growing demand for environmentally friendly manufacturing processes, reduction of waste generation, and adoption of green chemistry principles. API manufacturers are investing in technologies and practices that minimize the environmental impact of API production.
Active Pharmaceutical Ingredient Market Segmentations
Market Breakup by Molecule
- Small Molecule
- Large Molecule
Market Breakup by Type
- Innovative Active Pharmaceutical Ingredients
- Generic Active Pharmaceutical Ingredients
Market Breakup by Indications
- Acetaminophen
- Artemisinin
- Saxagliptin
- Sodium Chloride
- Ibuprofen Losartan Potassium
- Enoxaparin Sodium
- Rufinamide
- Naproxen
- Tamoxifen
- Others
Market Breakup by Type of Manufacturers
- Captive API Manufacturer
- Merchant API Manufacturer
Market Breakup by Potency
- Low to Moderate
- Potent to Highly Potent
Market Breakup by Therapeutic Applications
- Cardiology
- CNS & neurology
- Oncology
- Orthopedic
- Endocrinology
- Pulmonology
- Gastroenterology
- Nephrology
- Ophthalmology
- Other
Market Breakup by Distribution Channel
- Direct Tenders
- Retail Slaes
- Online Pharmacies
- Others
Market Breakup by Region
- North America
- United States of America
- Canada
- Europe
- United Kingdom
- Germany
- France
- Italy
- Others
- Asia Pacific
- China
- Japan
- India
- ASEAN
- Australia
- Others
- Latin America
- Brazil
- Argentina
- Mexico
- Others
- Middle East and Africa
- Saudi Arabia
- United Arab Emirates
- Nigeria
- South Africa
- Others
Active Pharmaceutical Ingredient Market Scenario
The global API (Active Pharmaceutical Ingredient) market plays a critical role in the pharmaceutical industry by providing the essential components necessary for the formulation and production of medications. The API market is driven by several factors, including the increasing prevalence of diseases, the demand for effective medications, and the growing generic drug market. The rising burden of chronic conditions, such as cardiovascular diseases, diabetes, and cancer, has fuelled the demand for APIs that can address these health challenges
The demand for generic drugs is also driving the growth of the API market. Generic drug manufacturers rely on APIs to produce affordable alternatives to branded medications, contributing to cost savings for patients and healthcare systems.
The market is characterized by a diverse landscape of API manufacturers, ranging from large multinational companies to specialized contract manufacturing organizations (CMOs). Outsourcing API production to CMOs has become a common practice, enabling pharmaceutical companies to focus on their core competencies in drug formulation and commercialization.
Overall, the API market is dynamic and constantly evolving to meet the demands of the pharmaceutical industry. The market's growth is driven by the increasing need for effective medications, the expansion of generic drugs, advancements in technology, and the focus on quality and regulatory compliance. As the global population continues to grow and healthcare needs increase, the API market is expected to expand further in the coming years.
Active Pharmaceutical Ingredient Market: Competitor Landscape
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- AstraZeneca
- Bristol-Myers Squibb
- Eli Lilly and Company
- F. Hoffmann-La Roche AG
- GlaxoSmithKline
- Johnson & Johnson
- Merck & Co., Inc.
- Novartis International AG
- Pfizer Inc.
- Sanofi
- Takeda Pharmaceutical Company Limited
- Celgene Corporation
- Amgen Inc.
- Gilead Sciences, Inc.
- Bayer AG
- AbbVie Inc.
- Regeneron Pharmaceuticals, Inc.
- Genentech
- Seattle Genetics, Inc.
- Aimmune Therapeutics
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Active Pharmaceutical Ingredient (API) Market Overview
3.1 Global Active Pharmaceutical Ingredient (API) Market Historical Value (2016-2022)
3.2 Global Active Pharmaceutical Ingredient (API) Market Forecast Value (2023-2031)
4 Global Active Pharmaceutical Ingredient (API) Market Landscape
4.1 Global Active Pharmaceutical Ingredient (API) Company Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Active Pharmaceutical Ingredient (API) Product Landscape
4.2.1 Analysis by Molecule Type
4.2.2 Analysis by Type
4.2.3 Analysis by Indications
4.2.4 Analysis by Types of Manufactures
4.2.5 Analysis by Potency
4.2.6 Analysis by Therapeutic Applications
4.2.7 Analysis by Distribution Channel
5 Global Active Pharmaceutical Ingredient (API) Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter's Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Active Pharmaceutical Ingredient (API) Market Segmentation
6.1 Global Active Pharmaceutical Ingredient (API) Market by Molecule
6.1.1 Market Overview
6.1.2 Small Molecule
6.1.3 Large Molecule
6.2 Global Active Pharmaceutical Ingredient (API) Market by Type
6.2.1 Market Overview
6.2.2 Innovative Active Pharmaceutical Ingredients
6.2.3 Generic Active Pharmaceutical Ingredients
6.3 Global Active Pharmaceutical Ingredient (API) Market by Indications
6.3.1 Market Overview
6.3.2 Acetaminophen
6.3.3 Artemisinin
6.3.4 Saxagliptin
6.3.5 Sodium Chloride
6.3.6 Ibuprofen Losartan Potassium
6.3.7 Enoxaparin Sodium
6.3.8 Rufinamide
6.3.9 Naproxen
6.3.10 Tamoxifen
6.3.11 Others
6.4 Global Active Pharmaceutical Ingredient (API) Market by Type of Manufacturers
6.4.1 Market Overview
6.4.2 Captive API Manufacturer
6.4.3 Merchant API Manufacturer
6.5 Global Active Pharmaceutical Ingredient (API) Market by Potency
6.5.1 Market Overview
6.5.2 Low to Moderate
6.5.3 Potent to Highly Potent
6.6 Global Active Pharmaceutical Ingredient (API) Market by Therapeutic Applications
6.6.1 Market Overview
6.6.2 Cardiology
6.6.3 CNS & neurology
6.6.4 Oncology
6.6.5 Orthopedic
6.6.6 Endocrinology
6.6.7 Pulmonology
6.6.8 Gastroenterology
6.6.9 Nephrology
6.6.10 Ophthalmology
6.6.11 Other
6.7 Global Active Pharmaceutical Ingredient (API) Market by Distribution Channel
6.7.1 Overview
6.7.2 Direct Tenders
6.7.3 Retail Slaes
6.7.4 Online Pharmacies
6.7.5 Others
6.8 Global Active Pharmaceutical Ingredient (API) Market by Region
6.8.1 Market Overview
6.8.2 North America
6.8.3 Europe
6.8.4 Asia Pacific
6.8.5 Latin America
6.8.6 Middle East and Africa
7 North America Active Pharmaceutical Ingredient (API) Market
7.1 Market Share by Country
7.2 United States of America
7.3 Canada
8 Europe Active Pharmaceutical Ingredient (API) Market
8.1 Market Share by Country
8.2 United Kingdom
8.3 Germany
8.4 France
8.5 Italy
8.6 Others
9 Asia Pacific Active Pharmaceutical Ingredient (API) Market
9.1 Market Share by Country
9.2 China
9.3 Japan
9.4 India
9.5 ASEAN
9.6 Australia
9.7 Others
10 Latin America Active Pharmaceutical Ingredient (API) Market
10.1 Market Share by Country
10.2 Brazil
10.3 Argentina
10.4 Mexico
10.5 Others
11 Middle East and Africa Active Pharmaceutical Ingredient (API) Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.4 Nigeria
11.5 South Africa
11.6 Others
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
16.1.5 Others
17 Supplier Landscape
17.1 AstraZeneca
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisitions
17.1.5 Certifications
17.2 Bristol-Myers Squibb
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisitions
17.2.5 Certifications
17.3 Eli Lilly and Company
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisitions
17.3.5 Certifications
17.4 F. Hoffmann-La Roche AG
17.4.1 Financial Analysis
17.4.2 Product Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisitions
17.4.5 Certifications
17.5 GlaxoSmithKline
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisitions
17.5.5 Certifications
17.6 Johnson & Johnson
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisitions
17.6.5 Certifications
17.7 Merck & Co., Inc.
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisitions
17.7.5 Certifications
17.8 Novartis International AG
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisitions
17.8.5 Certifications
17.9 Pfizer Inc.
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisitions
17.9.5 Certifications
17.10 Sanofi
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisitions
17.10.5 Certifications
17.11 Takeda Pharmaceutical Company Limited
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisitions
17.11.5 Certifications
17.12 Celgene Corporation
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisitions
17.12.5 Certifications
17.13 Amgen Inc.
17.13.1 Financial Analysis
17.13.2 Product Portfolio
17.13.3 Demographic Reach and Achievements
17.13.4 Mergers and Acquisitions
17.13.5 Certifications
17.14 Gilead Sciences, Inc.
17.14.1 Financial Analysis
17.14.2 Product Portfolio
17.14.3 Demographic Reach and Achievements
17.14.4 Mergers and Acquisitions
17.14.5 Certifications
17.15 Bayer AG
17.15.1 Financial Analysis
17.15.2 Product Portfolio
17.15.3 Demographic Reach and Achievements
17.15.4 Mergers and Acquisitions
17.15.5 Certifications
17.16 AbbVie Inc.
17.16.1 Financial Analysis
17.16.2 Product Portfolio
17.16.3 Demographic Reach and Achievements
17.16.4 Mergers and Acquisitions
17.16.5 Certifications
17.17 Regeneron Pharmaceuticals, Inc.
17.17.1 Financial Analysis
17.17.2 Product Portfolio
17.17.3 Demographic Reach and Achievements
17.17.4 Mergers and Acquisitions
17.17.5 Certifications
17.18 Genentech
17.18.1 Financial Analysis
17.18.2 Product Portfolio
17.18.3 Demographic Reach and Achievements
17.18.4 Mergers and Acquisitions
17.18.5 Certifications
17.19 Seattle Genetics, Inc.
17.19.1 Financial Analysis
17.19.2 Product Portfolio
17.19.3 Demographic Reach and Achievements
17.19.4 Mergers and Acquisitions
17.19.5 Certifications
17.20 Aimmune Therapeutics
17.20.1 Financial Analysis
17.20.2 Product Portfolio
17.20.3 Demographic Reach and Achievements
17.20.4 Mergers and Acquisitions
17.20.5 Certifications
18 Global Active Pharmaceutical Ingredient (API) Market - Distribution Model (Additional Insight)
18.1 Overview
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
21.3 Out-of-Pocket
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